Dyanavel XR

(amphetamine)
Dyanavel XR (amphetamine); CII
Full Prescribing Information
DailyMed Drug Information
Summary
Dyanavel XR is an extended-release amphetamine supplied as an oral suspension and as an extended-release tablet under one label, approved for ADHD from age 6. The moiety is amphetamine in a 3.2:1 d- to l- ratio, dosed in amphetamine base rather than salt, with immediate- and extended-release components for once-daily morning dosing. Its differentiator is being the only full-day amphetamine available as a true liquid. Schedule II; brand only.
Forms & Strengths
Extended-release oral suspension (bubblegum; 60 mL and 464 mL bottles): 2.5 mg/mL
Extended-release tablets (5 mg scored; may be chewed): 5 mg, 10 mg, 15 mg, 20 mg
Dosing
Age: ≥ 6 y/o
Onset: ~ 1 hour
Duration: up to 13 hours
Release Profile: combined immediate-release and extended-release components; this label publishes no percentage split
Initial Dose: 2.5 mg or 5 mg once daily in the morning, all patients ≥ 6
Titration: 2.5 mg to 10 mg per day every 4 to 7 days
Max Dose: 20 mg once daily
Considerations: Suspension and tablet substitute milligram for milligram; no other amphetamine does, because these strengths are base rather than salt. Titrate from scratch when switching in.
Pharmacology
Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
Delivery / Release: Ion-exchange resin supplies the extended fraction, amphetamine aspartate and dextroamphetamine sulfate the immediate. Median Tmax ~4 h (suspension), ~5 h (tablet)
Formulation: 3.2:1 d- to l-amphetamine, all strengths as amphetamine base; the critical fact when converting in
Metabolism: CYP2D6 forms active 4-hydroxyamphetamine; norephedrine also active. Half-life 12.4 h d- and 15.1 h l- in adults, 10.4 h and 12.1 h in children 6-12; urinary recovery is pH dependent
Pharmacogenomics: CYP2D6 is polymorphic; no genotype-based adjustment specified, so titrate slowly rather than genotype
Class Positioning: Against Adderall XR, a 3.2:1 rather than 3:1 ratio, base rather than salt dosing, 13 hour ceiling; against Adzenys XR-ODT, also base-dosed, it is the option when nothing solid is accepted
Impairment: renal and hepatic impairment unstudied for this product; both may prolong exposure
Indications
ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o
Off-Label Uses
None established. One indication, and no off-label use of this formulation is supported by graded pediatric evidence.
Where the evidence does not support use:
Children under 6: argued against by this label; the liquid makes small doses easy to give, which is why this needs saying.
Non-ADHD indications in youth: AHRQ CER 267 graded none; insufficient (AHRQ 2024).
Cognitive enhancement without ADHD: not supported.
Contraindications & Warnings
Boxed Warning: Abuse, misuse, and addiction. High potential for abuse, leading to substance use disorder; overdose and death, more so at higher doses or by non-oral routes. Assess risk before prescribing; reassess throughout.
Contraindicated:
Known hypersensitivity to amphetamine or components; angioedema and anaphylaxis reported
MAOI use, current or within 14 days, including linezolid and IV methylene blue
Use with caution (Warnings in this label, not contraindications):
Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death
Pre-existing hypertension, because BP and HR rise
Pre-existing psychosis; bipolar disorder, for treatment-emergent mania
Motor or verbal tics, or Tourette syndrome
Peripheral vasculopathy including Raynaud phenomenon
Renal or hepatic impairment; unstudied for this product, and both may prolong exposure
Substance use disorder in the patient or the household
Screen before starting:
Cardiac history, family history of sudden death or arrhythmia, and exam
Personal and family history of tics or Tourette syndrome
Mania risk: personal or family depression, bipolar disorder, suicide
Abuse and diversion risk; baseline height, weight, BP and HR
Drug Interactions
MAOIs (also linezolid, IV methylene blue): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Do not co-prescribe; confirm a 14 day washout.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, lithium, fentanyl, tramadol, buspirone, St John's Wort): serotonin syndrome. Start lower; stop both drugs if symptoms appear.
CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine, ritonavir): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower.
Urinary pH agents: acidifiers (ascorbic acid, fruit juice) lower amphetamine levels; alkalinizers (bicarbonate, acetazolamide, thiazides) raise them. The label directs an explicit dose adjustment either way.
Sympathomimetics (decongestants, beta-agonists): additive cardiovascular effect. Avoid OTC decongestants.
Laboratory assays: amphetamines elevate plasma corticosteroids and interfere with urinary steroid determinations; interpret rather than repeat.
Administration
Once daily in the morning, with or without food; a high-fat meal changes exposure only a few percent.
Suspension: shake hard before every dose; keep the bottle adapter inserted and measure with the pharmacy dispenser.
Tablet: may be chewed or swallowed whole, with no significant change in exposure or Tmax; only the 5 mg is scored.
Between the two Dyanavel XR forms: substitute milligram for milligram, the only such substitution the label permits.
From any other amphetamine: stop the previous drug and titrate from the beginning.
Avoid late dosing; with a 13 hour ceiling an afternoon dose reaches bedtime.
Store securely, preferably locked.
Side Effects
Common (extended-release amphetamine class list, per this label): decreased appetite and weight loss, insomnia, irritability, abdominal pain, dry mouth, headache, tremor, restlessness, bowel change, palpitations, tachycardia, elevated blood pressure.
Serious:
Sudden death, myocardial infarction and stroke with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor through it.
Psychosis or mania at recommended doses, roughly 0.1% in pooled stimulant trials; consider discontinuing.
Serotonin syndrome; stop both drugs and treat supportively.
Angioedema, anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis; stop and do not rechallenge.
Peripheral vasculopathy including Raynaud phenomenon, with digital ulceration reported; reduce or stop, refer if persistent.
Growth suppression; interrupt in a child not growing or gaining as expected.
New or worsening tics and Tourette syndrome.
Rhabdomyolysis, intestinal ischemia; priapism, a surgical emergency.
Monitoring & Labs
Cardiovascular: HR and BP at baseline, each dose change, and every 6 months; mean rise 2-4 mm Hg and 3-6 bpm.
Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if crossing two major percentile lines.
Appetite and sleep: every visit; with a 13 hour ceiling, sleep is what most often forces a timing change here.
Psychiatric: psychosis, mania, aggression, dysphoria at each visit and 2 weeks after any increase.
Tics and digits: ask about tics and inspect fingers and toes for colour change, coolness or unexplained wounds at each visit.
Dosing technique: watch the caregiver shake and draw a dose at first follow-up and whenever response turns erratic; an unshaken bottle looks like tolerance.
Abuse and diversion: adherence, bottle or pill counts and PDMP check at each refill.
Laboratory: none routinely required.
Discontinuation & Taper
Can be stopped abruptly at therapeutic doses; no taper required.
Physical dependence is labelled; withdrawal is dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite.
Late-evening rebound irritability and hunger is pharmacodynamic offset, not withdrawal.
Drug holidays suit appetite or growth as the limiting problem, less so a child who struggles outside school hours.
Pregnancy & Lactation
Pregnancy: Published data are insufficient to determine a drug-associated risk of major malformations or miscarriage. Amphetamines vasoconstrict placental vessels, may increase growth restriction, and stimulate uterine contractions.
Pregnancy, clinical: premature delivery and low birth weight in dependent mothers; background risk is 2% to 4% for major defects and 15% to 20% for miscarriage. Weigh rather than abstain.
Neonate: monitor for feeding difficulty, irritability, agitation and drowsiness.
Lactation: present in milk at relative infant doses of 2% to 13.8%, milk to plasma 1.9 to 7.5. No reported adverse infant effects; long-term neurodevelopment unknown; the label does not recommend breastfeeding.
Lactation, practical: some experts accept therapeutic doses, monitoring the infant for irritability, insomnia and feeding difficulty; prolactin is suppressed 25% to 40%. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388, https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/
Counseling Points
Counsel the family on:
Shaking the suspension hard before every dose; an unshaken bottle is the commonest cause of a Dyanavel XR that works some days and not others.
That the tablet may be chewed, which often solves swallowing without moving to the liquid.
The roughly 13 hour window, so a dose after mid-morning still works at bedtime.
Appetite suppression peaking midday; largest meal at breakfast and in the evening.
Never converting from a previous amphetamine milligram for milligram.
Storing the bottle locked, not with the other syrups; the bubblegum flavour is a formulation property.
Bringing a teacher rating scale to the next visit rather than a verbal impression.
Advise them to call for:
Chest pain on exertion, fainting, or a racing heart that does not settle.
New hallucinations, or new suspicious or fearful thinking.
Swelling of the lips, tongue or face, or any spreading rash or blistering.
Numbness, coldness or colour change in the fingers or toes.
A new or markedly worse tic; weight loss or clothes fitting more loosely.
A painful erection lasting more than a few hours.
References
DailyMed. Dyanavel XR (amphetamine) extended-release oral suspension and extended-release tablets prescribing information. NextWave Pharmaceuticals. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae304b29-0b40-40ec-ad0d-76b742d4a9b9
FDA. openFDA National Drug Code Directory, generic_name "amphetamine". 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22amphetamine%22&limit=1000
LactMed. Amphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/